Quality Assurance

  1. Ensuring Integrity: A Comprehensive Approach To CCI 1/8/2026

    Deterministic CCI testing ensures compliance in packaging. Learn how advanced methods like Vacuum Decay, HVLD, and Helium Leak Detection deliver results aligned with USP 1207 and global standards.

  2. The Pathway To Operational Readiness 6/24/2025

    Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.

  3. Overcome The Hidden Complexities Of mRNA Process Development 3/22/2023

    Explore the challenges behind the perceived simplicity of mRNA process development, as well as characterization strategies and models for predicting process outcomes at early stages.

  4. Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance 12/18/2024

    Airflow visualization techniques like Smoke Studies and CFD analyses are crucial for contamination control, aiding cleanroom qualification, environmental monitoring, and optimizing contamination control strategies under Annex 1.

  5. Autoinjector Testing: Addressing Sensitivity And Headspace Challenges 1/30/2026

    Micron‑level defects can jeopardize autoinjector sterility. Learn how vacuum decay offers a deterministic, repeatable way to verify container integrity and strengthen quality assurance.

  6. A Rapid Approach For Moisture Determination Of Lyophilized Product 11/13/2024

    Explore the limitations of traditional moisture determination techniques, an innovative approach using laser-based headspace analysis, and real-world case studies using this non-destructive method.

  7. CCI Testing And Revisions To EU Annex 1 1/2/2019

    The new language in EU Annex 1 will likely have a significant impact on your CCI testing practices. In this webinar CCI testing strategies and the proposed revisions to EU Annex 1 are discussed.

  8. Using Positive Controls In Container Closure Integrity Studies 1/2/2019

    This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.

  9. Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications 6/19/2025

    Discover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.

  10. The Sensitivity Trap: Building Confidence In CCIT Performance 3/2/2026

    Effective CCIT goes beyond micron claims, focusing instead on repeatability, confidence, and real‑world relevance. Learn how to define a defensible LOD and understand what auditors truly prioritize.